Finally, some good news out of California – at least when personal jurisdiction isn't the issue.
Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803 (Cal. App. June 30, 2017), and the result, particularly on the design side, was much more to our liking.
Indeed, there may well not have been post-BMS personal jurisdiction in Trejo either, since the plaintiffs were Hondurans injured in Honduras. It's not clear from the opinion where the drug at issue – an over-the-counter ("OTC") ibuprofen-based pain relief medication – was purchased. Somewhere in the United States, we gather, and it was then sent as a "care package" to the purchaser's Honduran relatives. Trejo, 2017 WL 2825803, at *2.
The drug was eventually taken, in Honduras, by someone other than its intended user, and that person, the eventual plaintiff, subsequently suffered Stevens-Johnson Syndrome ("SJS"), a nasty condition that we've encountered frequently on this blog. This particular exercise in litigation tourism was quite initially successful. A jury awarded over $50 million (including $15 million in punitive damages), finding for plaintiff on negligent failure to warn, negligent design, and strict liability design defect under the so-called "consumer expectation" test and the risk-benefit test. The defendant "won" (if you could call it that) on strict liability warning defect and design defect under the "risk/utility" test. Id. at *5. California not only allows plaintiffs two bites at the warning apple on separate negligence and strict liability theories, but three bites at the design apple under separate negligence, strict liability/consumer expectation design defect, and strict liability/risk/utility design defect theories. No wonder plaintiffs flock to the state.
On appeal, however, the plaintiff in Trejo lost it all.
The design defect rulings are the most significant for the rest of us.
First, Trejo becomes the fourth appellate court to hold that the impossibility preemption rationale of Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), applies generally, and it not limited to generic drugs – the others being Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016) (airplanes); Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir., 2015) (branded drugs), and In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015) (branded drugs). Trejo joins Sikkelee and Yates in applying Mensing/Bartlett to design defects. And Trejo is the first appellate decision to apply Mensing/Bartlett specifically to OTC drugs.
This is a good direction for the law to be moving. No appellate court has held that Mensing/Bartlett is limited to design defects in generic drugs.
Here's what the unanimous Second District Cal. App. panel in Trejo had to say about preemption:
While the FDCA contains an express preemption provision concerning OTC drugs (21 U.S.C. §379r) – with a great big exception that exempts "product liability" claims from preemption – express and implied preemption operate independently. Thus the savings clause for "product liability" doesn't preclude implied preemption where product liability claims are in conflict with federal law. Trejo, 2017 WL 2825803, at *23 ("[t]he savings clause does not foreclose the possibility that conflict preemption may arise from federal sources other than . . . §379r").
Plaintiff's design defect claim was that the defendant shouldn't have used ibuprofen at all, but rather dexibuprofen, an isomer of the drug in question, "even though the FDA has not approved dexibuprofen for sale in the United States." Id. at *5. That's right – plaintiff articulated a blatant stop-selling claim of the sort Bartlett had held preempted, and the Court of Appeal called "barnyard expletive" on plaintiff's tortured argument otherwise:
[Plaintiff] asserts that he did not argue that defendants "should have withdrawn [the drug] from the marketplace, or should have never sold it in the first place." This argument is merely a matter of semantics. No matter how plaintiff words his argument, the claim that defendants failed to sell dexibuprofen instead of ibuprofen requires the claim that defendants should have withdrawn [the drug] from the market because defendants could not have changed the active ingredient of [the drug] without undergoing an entirely new FDA drug application process.
Trejo, 2017 WL 2825803, at *21 n.20 (emphasis added).
The Bartlett " independence principle" also required preemption. It was impossible for the defendant to do what plaintiff contended state law required (materially change the drug's design) immediately because material design changes to OTC (and all) drugs (and medical devices) require the prior review by and approval of the FDA. "[F]ederal law prohibited the manufacturer from taking the remedial action required to avoid liability under [state] law." Trejo, 2017 WL 2825803, at *25 (quoting Bartlett, 133 S. Ct. at 2476). That ruling applied to all drugs:
Consistent with our conclusion that the savings clause . . . does not prevent the applicability of ordinary preemption principles in the nonprescription drug context, we agree . . . that Bartlett's holding is not limited to prescription drugs.
Trejo, 2017 WL 2825803, at *25 (emphasis added). The FDCA did not permit the defendant to substitute freely one active ingredient for another. "Dexibuprofen therefore would be a new drug, requiring a new drug application." Id.
[F]ederal law prohibited defendants from changing the design of [the drug] by selling dexibuprofen without prior FDA approval. Defendants accordingly could not have avoided design defect liability without violating federal law. "FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product."
Id. (quoting and following Yates, 808 F.3d at 298).
Preemption applied because the defendant could not have acted "unilaterally" to make the design change purportedly required by state product liability law – whether design defect is measured by consumer expectation or risk/utility:
Thus, under federal law [citations omtted] defendants could not unilaterally change the chemical composition of [the drug] from ibuprofen to dexibuprofen in order to satisfy consumer expectations or to increase the benefits or decrease the risks of [the drug]. Nor could they be required to stop selling [the drug] in order to avoid state liability. Plaintiff's design defect claim accordingly is preempted.
Id. at *26 (Bartlett citations omitted) (after quoting from a half-dozen cases listed in our post-Levine drug preemption cheat sheet).
Moreover, after trying the case as a straight-forward "you should have designed the product differently" claim, plaintiff could not attempt to convert it to some kind of quasi-warning-based case. Plaintiff had a real warning claim (which we'll get to) and couldn't convert one possible design related factor (presence of warnings) into the whole design ball of wax to avoid preemption after having tried a different case to the jury. Id.
But there's more on design first.
Second, as we mentioned, California allows plaintiffs generally to prosecute design defect claims on either a consumer expectation or risk/utility theory of liability. Not anymore in prescription medical product cases after Trejo. Trejo also held, quite apart from preemption, that the consumer expectation theory was inapplicable to complicated products such as OTC drugs – and thus, we would argue, a fortiori would be inapplicable to prescription medical products.
The consumer expectation test is only appropriate for products that "everyday experience" allows consumers generally to have safety expectations about:
[T]he consumer expectations test is reserved for cases in which the everyday experience of the product's users permits a conclusion that the product's design violated minimum safety assumptions, and is thus defective regardless of expert opinion about the merits of the design.
Trejo, 2017 WL 2825803, at *27 (quoting Soule v. General Motors Corp., 882 P.2d 298, 308 (Cal. 1994)) (emphasis original). OTC drugs – let alone prescription products – aren't that. Plaintiff tried the case with expert witnesses, which is a no-no under the consumer expectation theory. That plaintiff did so demonstrated the theory's inapplicability.
The circumstances of [the drug's] failure involve technical details and expert testimony regarding the effect of the product upon an individual plaintiff's health, and the ultimate question of whether [the drug] was defectively designed calls for a careful assessment of feasibility, practicality, risk, and benefit.
Id. at *30 (citations and quotation marks omitted). SJS was an "unusual reaction" to the drug, thus "expert testimony was required to explain plaintiff's theory." Id. "Accordingly, we conclude that the consumer expectation test should not have been applied." Id.
In light of this complexity, plaintiff's excuse for consumer expectations fell in the same barnyard as his argument against stop selling preemption. Simply testifying that "I didn't expect to get hurt" didn't cut it:
Plaintiff here contends that the consumer expectation test applies because the ordinary consumer does not expect to contract SJS/TEN from taking OTC [ibuprofen]. However, it could be said that any injury from the intended or foreseeable use of a product is not expected by the ordinary consumer. If this were the end of the inquiry, the consumer expectation test always would apply and every product would be found to have a design defect.
Trejo, 2017 WL 2825803, at *29 (emphasis added). A consumer cannot, by playing dumb, bootstrap himself into a consumer expectation claim. "[T]he consumer expectation test does not apply merely because the consumer states that he or she did not expect to be injured by the product." Id. Admittedly, we haven't seen that many California plaintiffs audacious (or desperate) enough to utilize consumer expectation theories against FDA-approved products; nonetheless we're beyond pleased now to have explicit appellate authority precluding this theory of liability against our clients.
After Trejo, it becomes a lot harder for any plaintiff to pursue a design defect claim against a prescription medical product in California. If the design considerations that go into OTC drugs are too complex and involved to allow use of the consumer expectation theory of liability, than that theory is even less available to more sophisticated prescription products whose risks and benefits are so esoteric that the FDA has concluded that they should be dispensed only after evaluation by medical doctors. Likewise, the Mensing/Bartlett preemption rationale against design defects is equally applicable to all FDA regulated products. Can a branded drug manufacturer change its product's active ingredient – or any other aspect of the product that materially affects product safety? No. And neither can a medical device manufacturer. Effectively, all design defect claims that could make a difference in a product liability action (that materially affect "safety") require prior FDA review, and thus should be preempted under Trejo and the Mensing/Bartlett independence principle.
That's still not all. We still have Trejo's disposition of the warning-related aspects of the verdict to discuss.
Third, the Court of Appeal unanimously held that the jury's verdict for the defendant on strict liability warning defect was fatally inconsistent with its verdict for plaintiff on negligent failure to warn. Trejo, 2017 WL 2825803, at *8-14. From a national perspective, this result is less important than the design defect aspects we just finished with, because disposition of the warning claim has to do with the interaction of California's peculiar warning-based legal doctrines, which still attempt to maintain a difference between negligence and strict liability in the warning context. Most other states treat them interchangeably.
It's still important in Trejo, however. $50 million is $50 million.
Briefly – because the whole thing reeks of hair-splitting to us – "both the strict liability and negligence theories were premised on a single alleged defect." Id. at *8. "[U]nder either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury." Id. at *6. However, "strict liability, which was developed to ease a claimant's burden of proof, requires proof of fewer elements than negligence." Id. Thus, negligence requires "an additional element, namely, that the defect in the product was due to negligence of the defendant." Id. Where (as here) the claimed defect under both theories is the same, that means that strict liability simply eliminates an necessary element, so that "a positive verdict on the latter [negligence, is] difficult to explain if strict liability cannot be found." Id.
Exactly that happened in Trejo, and it cost plaintiff $50 million. It wasn't the first time, either. A previous decision, Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 262-64 (Cal. App. 1999), was directly on point, forthrightly holding that "[a]s a practical matter then, the difference in the two concepts [negligence and strict liability] is so small as to make no difference." Id. at 263. The jury's finding for the defendant on the "easier" warning defect claim was necessarily inconsistent with its finding for plaintiff on the "harder to prove" negligent warning claim. Trejo, 2017 WL 2825803, at *14 ("The jury's special verdict on negligent failure to warn is fatally inconsistent with its verdict on strict liability failure to warn and must be reversed.").
Who knows what would have happened if this plaintiff had not insisted on more than one bite at the apple? That's what we'll find out on retrial. We have no idea when that might be however, since further appellate review in Trejo is certainly possible. In this respect, we are reminded that Bartlett, like Trejo, was also an SJS case.
This article is presented for informational purposes only and is not intended to constitute legal advice.
